Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017243
Company: CURIUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTRA-TECHNEKOW FM TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 0.25-3 CI/GENERATOR SOLUTION;INTRAVENOUS Discontinued None No No
ULTRA-TECHNEKOW FM TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 1-19 CI/GENERATOR SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/23/1973 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/30/2017 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

05/04/2015 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017243Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017243Orig1s046ltr.pdf
02/16/2015 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/20/2013 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017243Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017243Orig1s044ltr.pdf
02/18/2014 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017243s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017243Orig1s043ltr.pdf
11/18/2013 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/11/2013 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/15/2013 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

05/10/2013 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

05/13/2013 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/21/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

11/10/2008 SUPPL-30 Labeling

Label is not available on this site.

03/27/2006 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017243s028ltr.pdf
10/15/2004 SUPPL-25 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17243s025ltr.pdf
01/16/2003 SUPPL-22 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17243scs022ltr.pdf
04/19/2002 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/04/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1999 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/14/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-16 Labeling

Label is not available on this site.

06/18/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/20/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1984 SUPPL-10 Labeling

Label is not available on this site.

06/30/1982 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/07/1982 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1979 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/23/1977 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/27/1977 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/08/1976 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/04/2015 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017243Orig1s046lbl.pdf
02/18/2014 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017243s043lbl.pdf
12/20/2013 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017243Orig1s044lbl.pdf
10/15/2004 SUPPL-25 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English